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FDA 510(k)

POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES

K-Number: K954462 · 1995-10-13

ApplicantIntl. Trade Management Co.
Decision Date1995-10-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Trade Management Co.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K954462. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES?

POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Intl. Trade Management Co.. The 510(k) number is K954462.

When did POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES receive FDA 510(k) clearance?

POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES received FDA 510(k) clearance on 1995-10-13, under 510(k) number K954462.

Who is the listed applicant for POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES?

The FDA 510(k) record lists Intl. Trade Management Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES?

The FDA product code for POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES is KGO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intl. Trade Management Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953299POLYKOTEK951513JAIK950468POWDER FREE STERILE LATEX SURGEONS GLOVESK950467POWDER FREE PATIENT EXAMINATION GLOVESK946203JAI POWDERFREE LATEX EXAMINATION GLOVES

Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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